BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 1892057 · Received October 26, 2010

    Report

    Report Number
    1627487-2010-03104
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 4 (SEE MFR REPORT #S 1627487-2010-03102, 1627487-2010-03103, AND 1627487-2010-03105, RESPECTIVELY FOR DEVICES 1, 2 AND 4.) THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. REPROGRAMMING ATTEMPTS TO RECAPTURE EFFECTIVE STIMULATION PROVED UNSUCCESSFUL. X-RAYS WERE TAKEN WHICH REVEALED THAT THE PATIENT'S LEADS AND ANCHORS HAD MIGRATED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPLACE THE PATIENT'S LEADS; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LOCK ANCHOR SPINAL CORD STIMULATION ACCESSORY LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 1192 2926160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention